期刊文献+

GC法测定盐酸美金刚原料药的有关物质 被引量:1

Determination of the Related Substance in Memantine Hydrochloride by HPLC
下载PDF
导出
摘要 采用GC法测定盐酸美金刚原料药的有关物质。方法:采用DB-17(30 m×0.25 mm×0.25μm)色谱柱,氮气为载气,FID检测器温度300℃,进样口温度为220℃。结果:盐酸美金刚及其已知杂质(杂质A、杂质B、杂质C、杂质E、杂质F)的线性范围分别为5~120μg/m L;平均回收率分别为97.5%、95.3%、96.7%、94.2%和98.4%;结论:本法简便、准确、可靠、适合于盐酸美金刚原料药有关物质测定。 To establish an GC method For quantitative determination of Memantine Hydrochloride. Methods: The analytical column was DB-17(30 m×0.25 mm×0.25 μm), carrier gas was helium for chromatography R, detector was 300 ℃, detection was flame ionization,injection port was 220 ℃. Results: The linear ranges of Memantine Hydrochloride and the related substance were 5~120 μg/m L. The average recovery of Memantine Hydrochloride was 97.5 %、95.3 %、96.7 %、94.2 % and 98.4 %. Conclusion: The method to determine the assay of Memantine Hydrochloride is simple, sensitive and accurate.
出处 《广东化工》 CAS 2015年第20期134-134,131,共2页 Guangdong Chemical Industry
关键词 GC法 FID 有关物质 测定 Memantine Hydrochloride GC method the related substance determination
  • 相关文献

参考文献8

  • 1US. Pharmacopoeial Convention. Pramipexole Dihydrochlofide[M]. United States Pharmaeopoei (USP 36). 被引量:1
  • 2European Pharmacopoeial Convention Pramipexole Dihydrochloride[M]. European Pharmacopoeia 8.0 (EP 8.0). 被引量:1
  • 3Kraus George A. Ames Iowa. Metllod for the synthesis of adamamane amines[P]. US 5 599 998, 1997. 被引量:1
  • 4中国药典2010附录XIXA药品质量标准分析方法验证指导原则. 被引量:2
  • 5ICHQ2. R1. Validation. Analytical. Procedures. 被引量:1
  • 6ICH Steering Committee. Q3A: Impurities in New Drug Products (Revised Guideline), ICH Quality. 被引量:1
  • 7Duh TH, Wu HL, Kou HS, et al. (2-Naphthoxy)acetyl chloride, a simple fluorescent reagent[J]. J ChromatogrA, 2003, 987(1-2): 205-209. 被引量:1
  • 8MobiS n J . Pharmacologic rationale for memantine in chronic-hyp0perfusi0n, especially vascular demantia[J]. Alzheimers Dis Assoc Disord, 1999, 13(Suppl3): S172-178. 被引量:1

共引文献1

同被引文献8

引证文献1

二级引证文献1

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部